As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. With the FDA's risk-based regulatory initiatives focusing new attention on the risks of cross-contamination understanding lifecycle management techniques for an effective cleaning validation program is paramount. This training course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.

• Identify and characterize potential residues including product, processing aids, cleaning agents, and adventitious agents
• Apply appropriate analytical methodology for selected residues
• Determine suitable sampling techniques and the selection of sampling locations that present a challenge for the cleaning process
• Calculate residue limits that meet all necessary regulatory requirements
• Create scientifically sound rationales, validation protocols, and reports
• Manage the challenges of multi-product facilities in the establishment of limits, determination of validation strategies, and maintaining the validated state
• Understand campaign-based production strategies for effective and scientifically sound validation
• Differentiate the requirements for cleaning validation when using manual, semi-automatic, and automatic cleaning technologies
• Determine scientific grouping or bracketing approaches
• Comprehend the pitfalls inherent in cleaning after the production of biopharmaceutical and pharmaceutical products
• Accomplish analytical method validation and recovery study requirements in cost-effective studies that provide the necessary assurance of an analytical system
• Evaluate cleaning practices, limit calculations, scientific rationales, and validation documents through internal self-audits to ensure compliance with ever-changing regulatory needs
• Practice hands-on exercises designed to reinforce core competencies and job-focused skills

cleaning vaildation

Online Registration Browse website https://www.ispeth.org/event/ca-t17/